Devices for Tissue Augmentation

ABSTRACT

Devices, method to produce devices and methods to perform bone augmentation using a bag having two membranes on one side and one membrane on the other side which is preferably perforated. The bag can be filled with bone augmenting material. The bag can be used in the jaws while placing the side with the one membrane towards the jaw bone and the side with the two membranes towards the gingiva.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates mainly to devices for tissue augmentationand/or bone augmentation, methods of producing the devices and methodsof using the devices. The devices can be used also for other treatments,for example directional release of medications and/or radiation.

Treatment of edentulous patients with dental implants called alsoosseointegrated fixtures, which are made mainly of titanium and/orzirconium, is a well known procedure in the art. The procedure includesinstalling a dental implant in the alveolar bone of an at leastpartially edentulous jaw. Usually several months are required for properhealing after implant installation. After healing, an abutment isinstalled on the (called also “coronal”) portion of the dental implant.After several weeks, an artificial tooth may be mounted on the abutmentand the procedure is complete. It is also possible in some cases toconnect the abutment and/or the crown and/or the bridge and/or thedenture and/or a dolder bar and/or any dental element to the dentalimplant much earlier and even in the same day.

Installation of implants requires sufficient alveolar bone, generallyabout 10 mm height and 7 mm width.

When a tooth is removed, the alveolar bone is gradually resorbed becauseof the absence of stimulus of ossification-inducing pressure from theteeth. As the resorption process advances, the size of the bone getsreduced, i.e. the bone on which the dental roots are positioned—thealveolar ridge start shrinking.

The absence of just one tooth can cause modifications throughout thedental arch and even prompt a possible softening (loss of insertion)which may cause the loss of other teeth. The absence of several teethaggravates the problem. Bone loss may finally modify the patient'sappearance and, depending on the loss, may make him incapable ofreceiving bridges, implants or even dentures.

It is then necessary to carry out several surgical operations toreconstruct the alveolar ridge of the maxilla (called also the maxillarybone) or mandible (called also mandibular bone or mandibular).

Although these methods of surgical reconstruction have been successfullyperformed, this type of operation has had drawbacks. Certain methodshave involved opening the mucoperiosteal tissue called also periostealtissue and/or gums and/or gingiva along the entire length of theatrophic alveolar ridge and then placing a bone graft material and amembrane on top of the graft and then suturing the delicatemucoperiosteal tissue back together to cover the membrane. The role ofthe membrane is to maintain the bone graft in its place and to preventthe mucoepithelium from growing into the graft and interfering with theprocess of bone regeneration. This surgical operation has drawbacks andusually only limited amount of bone regeneration can be achieved.

U.S. Pat. No. 7,749,267 to Karmon and U.S. Pat. No. 8,622,739 to Karmon,the entire disclosures of which are hereby incorporated by reference,disclose devices and methods to overcome some of these drawbacks. Karmondiscloses a bag to be placed between the bone and the periosteal tissue,which can be filled with bone augmenting material. The bag can beperforated on the side facing the bone while the side facing theperiosteal tissue can be made from a guided bone regeneration membraneand can have different properties than the perforated side. U.S. patentapplication No. 20150320463 to Karmon, the entire disclosure of which ishereby incorporated by reference, disclose devices and methods to treatfractures with bags that can be filled with bone augmenting material andcan have a perforated side.

However preparation of such a bag is not trivial, especially when it ismade from biological material like collagen or pericardium. Theinsertion of the bag inside a subperiosteal tunnel is not trivialeither, especially in the posterior region of lower jaw, adjacent themental nerve, which can be damaged during the insertion of the bag.

Therefore there is a need for better devices and methods for producingthe bags and/or containers and methods that will allow safer insertionof the bags inside a subperiosteal tunnel, if a subperiosteal tunnel isused.

SUMMARY OF THE INVENTION

The present invention provides devices and methods to perform tissueregeneration. The following embodiments will focus on bone regenerationin the jaws, however similar devices can be used for other bones and/ortissues in the body. For example the bags can be used for regenerationof cartilage tissue in the knee or in other joints.

One of the inventions is a bag having one layer a membrane on side andtwo layers of a guided bone regeneration membrane on the opposite side.The side with one layer can be perforated with holes that allow bontissue ingrowth. The bag can be completely bioresorbable. The side withthe one layer can be made from other materials than the side with thetwo membranes. The side with the one layer can be made to be resorbedfaster than the side with the two layers, however both sides can befully and/or partially non-resorbable. The bag can be filled with amaterial that promotes bone growth. The bag can be placed in the jaw sothe side with the one layer will be placed towards the bone and sidewith the two layers towards the gums. The side with the two layers canbe such that it prevents soft tissue ingrowth inside the bag that willinterfere with bone regeneration process.

Other objects and features of the present invention will become apparentin the following detailed description when taken in connection with theaccompanying drawings which disclose several embodiments of theinvention. It is to be understood that the drawings are designed for thepurpose of illustration only and are not intended as a definition of thelimits of the invention.

It is also to be understood that any combination of the embodimentsdescribed hereafter can be used although these combinations are notexplicitly described. The number of possible combinations of differentelements in different relations to each other and the number of optionsof using the devices is enormous. Therefore only several embodiments aredescribed and illustrated.

The present invention provides a number of novel features, each of whichis believed to be of patentable significance, and which can be combinedin various combinations. A selection of the combinations will bedescribed below, and other possible combinations will be clear to oneordinarily skilled in the art on the basis of this description. Allfeatures described below in the context of one exemplary embodiment ofthe present invention should be understood as being equally applicableto other embodiments except where the features are clearly incompatibleor it is explicitly stated otherwise.

Thus, according to the teachings of the present invention there isprovided a device for treating patients in need for tissue regenerationcomprising:

A device for treating patients in need for tissue regenerationcomprising:

-   -   a sheet, the sheet has a perforated region having several holes        with diameter of more than 30 microns, the sheet has a first        side region located at the right side of the perforated region,        the sheet has a second side region located at the left side of        the perforated region, the first side region has no pores or has        pores such that the largest pore in the first side region has a        diameter of up to 30 microns.

According to a further feature of the present invention, the second sideregion has no pores or has pores such that the largest pore in thesecond side region has a diameter of up to 30 microns.

According to a further feature of the present invention, the first andsecond side regions are placed above the perforated region forming asoft tissue blocking region above the perforated region, the soft tissueblocking region has no pores or has pores such that the largest pore inthe soft tissue blocking region has a diameter of up to 30 microns.

According to a further feature of the present invention, the sheet has amiddle region having several holes with diameter of more than 30microns, the sheet has a first side region located at the right side ofthe middle region, the sheet has a second side region located at theleft side of the middle region, the first and second side regions areplaced above the perforated region forming a soft tissue blocking regionabove the perforated region, pores which are larger than 20 microns areabsent from the soft tissue blocking region.

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover.

According to a further feature of the present invention, said secondside region has a slot surrounding partially an area of said second sideregion to form a second retractable cover.

According to a further feature of the present invention said secondretractable cover being larger than said first retractable cover, saidsecond retractable cover overlaps and cover said first retractable coverin said soft-tissue blocking region to form a side opening in saidsoft-tissue blocking region when said first and second retractablecovers are being retracted.

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover, said second side region has aslot surrounding partially an area of said second side region to form asecond retractable cover, said second retractable cover being largerthan said first retractable cover, said second retractable coveroverlaps and cover said first retractable cover in said soft-tissueblocking region to form a side opening in said soft-tissue blockingregion when said first and second retractable covers are beingretracted.

According to a further feature of the present invention, said firstretractable cover and said second retractable cover are being designedto be retracted to different directions.

According to a further feature of the present invention, said firstretractable cover has a retractable cover fixating slot adjacent to saidnon-linear slot in said first side region, the length of saidretractable cover fixating slot being compatible with the width of saidsecond retractable cover.

According to a further feature of the present invention, the middleregion has several holes with diameter of more than 30 microns to form aperforated region.

According to a further feature of the present invention, the middleregion has more than 10 holes.

According to a further feature of the present invention, the middleregion bio-dissipate faster than the first and second side regions.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least partthe sheet is a guided regeneration membrane.

According to a further feature of the present invention, at least partthe sheet is a pericardium membrane.

According to a further feature of the present invention, at least partthe sheet is a collagen membrane.

According to a further feature of the present invention, at least partthe sheet is a synthetic membrane.

According to a further feature of the present invention, the first sideregion is connected to the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by an adhesive layerlocated between the first side region and the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by sutures.

According to a further feature of the present invention, the first sideregion is connected to the second side region by heat and/or pressure.

According to a further feature of the present invention, the first sideregion is connected to the second side region in a non-continues mannerso as to have non connected areas of the side regions between connectedareas of the side regions.

According to a further feature of the present invention, the first sideregion has a slot and the second side region has a connecting extension,part of the connecting extension of the second side region having awidth which is larger than the length of the slot in the first sideregion.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slot in the first side region.

According to a further feature of the present invention, the first sideregion has two adjacent slots and the second side region has aconnecting extension, part of the connecting extension of the secondside region having a width which is larger than the length of the slotsin the first side region.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slots of the first side region.

According to a further feature of the present invention, the second sideregion has a slot and the first side region has a connecting extension,part of the connecting extension of the first side region having a widthwhich is larger than the length of the slot in the second side region.

According to a further feature of the present invention, the part of theconnecting extension of the first side region being inserted through theslot in the second side region.

According to a further feature of the present invention, one edge of themiddle region being connected to the tissue blocking region to form abag having a filling opening adjacent the opposite edge of theperforated region.

According to a further feature of the present invention, the middleregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the middle region to form a bag.

According to a further feature of the present invention, the middleregion includes an edge closing extension, the edge closing extensionbeing placed between the first side region and the second side region toform a bag.

According to a further feature of the present invention, a boneaugmenting material is located between the middle region and the softtissue blocking region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the middle region and thesoft tissue blocking region, the diameter of the particles of the boneaugmenting material are larger than the diameter of the holes in theperforated region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the middle region and thesoft tissue blocking region, the diameter of the particles of the boneaugmenting material are smaller than the diameter of the holes in themiddle region and the particles are in a flowable material.

According to a further feature of the present invention, the edges ofthe middle region being connected to the tissue blocking region to forma bag, a bone augmenting material being inside the bag.

Thus, according to the teachings of the present invention there isprovided a device for treating patients in need for tissue regenerationcomprising:

-   -   a sheet, the sheet has a perforated region having several holes        with diameter of more than 30 microns, the sheet has a first        side region located at the right side of the perforated region,        the sheet has a second side region located at the left side of        the perforated region, the first and second side regions are        placed above the perforated region forming a soft tissue        blocking region above the perforated region, pores which are        larger than 20 microns are absent from the soft tissue blocking        region.

It must be clear that the sequence of placing the side regions and anyother elements of the device as described above and hereafter can bechanged, as long as a bag is formed. For example, the first side regioncan be placed over the perforated region and the second side region tobe above the first side region. For example, the second side region canbe placed over the perforated region and the first side region to beabove the second side region

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover.

According to a further feature of the present invention, said secondside region has a slot surrounding partially an area of said second sideregion to form a second retractable cover.

According to a further feature of the present invention said secondretractable cover being larger than said first retractable cover, saidsecond retractable cover overlaps and cover said first retractable coverin said soft-tissue blocking region to form a side opening in saidsoft-tissue blocking region when said first and second retractablecovers are being retracted.

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover, said second side region has aslot surrounding partially an area of said second side region to form asecond retractable cover, said second retractable cover being largerthan said first retractable cover, said second retractable coveroverlaps and cover said first retractable cover in said soft-tissueblocking region to form a side opening in said soft-tissue blockingregion when said first and second retractable covers are beingretracted.

According to a further feature of the present invention, said firstretractable cover and said second retractable cover are being designedto be retracted to different directions.

According to a further feature of the present invention, said first sideregion has a retractable cover fixating slot adjacent to said non-linearslot in said first sheet, the length of said retractable cover fixatingslot being compatible with the width of said second retractable cover.

According to a further feature of the present invention, the perforatedregion has more than 10 holes.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least partthe sheet is a guided regeneration membrane.

According to a further feature of the present invention, at least partthe sheet is a pericardium membrane.

According to a further feature of the present invention, at least partthe sheet is a collagen membrane.

According to a further feature of the present invention, at least partthe sheet is a synthetic membrane.

According to a further feature of the present invention, the first sideregion is connected to the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by an adhesive layerlocated between the first side region and the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by sutures.

According to a further feature of the present invention, the first sideregion is connected to the second side region by heat and/or pressure.

According to a further feature of the present invention, the first sideregion is connected to the second side region in a non-continues mannerso as to have non connected areas of the side regions between connectedareas of the side regions.

According to a further feature of the present invention, the first sideregion has a slot and the second side region has a connecting extension,part of the connecting extension of the second side region having awidth which is larger than the length of the slot in the first sideregion.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slot in the first side region.

According to a further feature of the present invention, the first sideregion has two adjacent slots and the second side region has aconnecting extension, part of the connecting extension of the secondside region having a width which is larger than the length of the slotsin the first side region.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slots of the first side region.

According to a further feature of the present invention, the second sideregion has a slot and the first side region has a connecting extension,part of the connecting extension of the first side region having a widthwhich is larger than the length of the slot in the second side region.

According to a further feature of the present invention, the part of theconnecting extension of the first side region being inserted through theslot in the second side region.

According to a further feature of the present invention, one edge of theperforated region being connected to the tissue blocking region to forma bag having a filling opening adjacent the opposite edge of theperforated region.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the holes in the perforated regionto form a bag.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed between the first side region and the second side region toform a bag.

According to a further feature of the present invention, a boneaugmenting material is located between the perforated region and thesoft tissue blocking region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are larger than the diameter of the holes inthe perforated region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are smaller than the diameter of the holes inthe perforated region and the particles are in a flowable material.

According to a further feature of the present invention, the edges ofthe perforated region being connected to the tissue blocking region toform a bag, a bone augmenting material being inside the bag.

Thus, according to the teachings of the present invention there isprovided a device for treating patients in need for tissue regenerationcomprising:

-   -   a tube, a first aspect of the tube has a perforated region        having several holes with diameter of more than 30 microns, a        second aspect of the tube has a soft tissue blocking region        located above the perforated region, the soft tissue blocking        region has a first sheet and a second sheet, the second sheet        located above the first sheet, pores which are larger than 20        microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, said firstsheet has a slot surrounding partially an area of said first sheet toform a first retractable cover.

According to a further feature of the present invention, said secondsheet has a slot surrounding partially an area of said second sheet toform a second retractable cover.

According to a further feature of the present invention said secondretractable cover being larger than said first retractable cover, saidsecond retractable cover overlaps and cover said first retractable coverin said soft-tissue blocking region to form a side opening in saidsoft-tissue blocking region when said first and second retractablecovers are being retracted.

According to a further feature of the present invention, said firstsheet has a slot surrounding partially an area of said first sheet toform a first retractable cover, said second sheet has a slot surroundingpartially an area of said second sheet to form a second retractablecover, said second retractable cover being larger than said firstretractable cover, said second retractable cover overlaps and cover saidfirst retractable cover in said soft-tissue blocking region to form aside opening in said soft-tissue blocking region when said first andsecond retractable covers are being retracted.

According to a further feature of the present invention, said firstretractable cover and said second retractable cover are being designedto be retracted to different directions.

According to a further feature of the present invention, said firstretractable cover has a retractable cover fixating slot adjacent to saidnon-linear slot in said first sheet, the length of said retractablecover fixating slot being compatible with the width of said secondretractable cover.

According to a further feature of the present invention, the perforatedregion has more than 10 holes.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least one ofsaid sheets is a guided regeneration membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a pericardium membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a collagen membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a synthetic membrane.

According to a further feature of the present invention, the first sheetregion is connected to the second sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by an adhesive layer located betweenthe first sheet and the second sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by sutures.

According to a further feature of the present invention, the first sheetis connected to the second sheet by heat and/or pressure.

According to a further feature of the present invention, the first sheetis connected to the second sheet in a non-continues manner so as to havenon connected areas of the sheets between connected areas of the sheets.

According to a further feature of the present invention, one edge of theperforated region being connected to the tissue blocking region to forma bag having a filling opening adjacent the opposite edge of theperforated region.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the holes in the perforated regionto form a bag.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed between the first sheet and the second sheet to form a bag.

According to a further feature of the present invention, a boneaugmenting material is located between the perforated region and thesoft tissue blocking region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are larger than the diameter of the holes inthe perforated region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are smaller than the diameter of the holes inthe perforated region and the particles are in a flowable material.

According to a further feature of the present invention, the edges ofthe perforated region being connected to the soft tissue blocking regionto form a bag, a bone augmenting material being inside the bag.

Thus, according to the teachings of the present invention there isprovided a device for treating patients in need for tissue regenerationcomprising:

-   -   a bag, a first aspect of the bag has a perforated region having        several holes with diameter of more than 30 microns, a second        aspect of the bag has a soft tissue blocking region located        above the perforated region, the soft tissue blocking region has        a first sheet and a second sheet, the second sheet located above        the first sheet, pores which are larger than 20 microns are        absent from the soft tissue blocking region.

According to a further feature of the present invention, said firstsheet has a slot surrounding partially an area of said first sheet toform a first retractable cover.

According to a further feature of the present invention, said secondsheet has a slot surrounding partially an area of said second sheet toform a second retractable cover.

According to a further feature of the present invention said secondretractable cover being larger than said first retractable cover, saidsecond retractable cover overlaps and cover said first retractable coverin said soft-tissue blocking region to form a side opening in saidsoft-tissue blocking region when said first and second retractablecovers are being retracted.

According to a further feature of the present invention, said firstsheet has a slot surrounding partially an area of said first sheet toform a first retractable cover, said second sheet has a slot surroundingpartially an area of said second sheet to form a second retractablecover, said second retractable cover being larger than said firstretractable cover, said second retractable cover overlaps and cover saidfirst retractable cover in said soft-tissue blocking region to form aside opening in said soft-tissue blocking region when said first andsecond retractable covers are being retracted.

According to a further feature of the present invention, said firstretractable cover and said second retractable cover are being designedto be retracted to different directions.

According to a further feature of the present invention, said firstretractable cover has a retractable cover fixating slot adjacent to saidnon-linear slot in said first sheet, the length of said retractablecover fixating slot being compatible with the width of said secondretractable cover.

According to a further feature of the present invention, the perforatedregion has more than 10 holes.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least one ofsaid sheets is a guided regeneration membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a pericardium membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a collagen membrane.

According to a further feature of the present invention, at least one ofsaid sheets is a synthetic membrane.

According to a further feature of the present invention, the first sheetis connected to the second sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by an adhesive layer located betweenthe first sheet and the second sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by sutures.

According to a further feature of the present invention, the first sheetis connected to the second sheet by heat and/or pressure.

According to a further feature of the present invention, the first sheetis connected to the second sheet in a non-continues manner so as to havenon connected areas of the sheets between connected areas of the sheets.

According to a further feature of the present invention, the bag havinga filling opening adjacent one edge of the perforated region.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the holes in the perforated regionto close the bag.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed between the first sheet and the second sheet to close thebag.

According to a further feature of the present invention, a boneaugmenting material is located between the perforated region and thesoft tissue blocking region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are larger than the diameter of the holes inthe perforated region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are smaller than the diameter of the holes inthe perforated region and the particles are in a flowable material.

According to a further feature of the present invention, an edge of theperforated region being connected to the soft tissue blocking region toclose the bag, a bone augmenting material being inside the bag.

Thus, according to the teachings of the present invention there isprovided a method for preparing a device for treating patients in needfor tissue regeneration comprising:

-   -   a. perforating a region of a sheet with several holes having a        diameter of more than 30 microns to form a perforated region;    -   b. folding a first side region of the sheet located on the right        side of the perforated region above the perforated region;    -   c. folding a second side region of the sheet located on the left        side of the perforated region above the first side region so the        first and second side regions form a soft tissue blocking        region, pores which are larger than 20 microns are absent from        the soft tissue blocking region.

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover.

According to a further feature of the present invention, said secondside region has a slot surrounding partially an area of said second sideregion to form a second retractable cover.

According to a further feature of the present invention said secondretractable cover being larger than said first retractable cover, saidsecond retractable cover overlaps and cover said first retractable coverin said soft-tissue blocking region to form a side opening in saidsoft-tissue blocking region when said first and second retractablecovers are being retracted.

According to a further feature of the present invention, said first sideregion has a slot surrounding partially an area of said first sideregion to form a first retractable cover, said second side region has aslot surrounding partially an area of said second side region to form asecond retractable cover, said second retractable cover being largerthan said first retractable cover, said second retractable coveroverlaps and cover said first retractable cover in said soft-tissueblocking region to form a side opening in said soft-tissue blockingregion when said first and second retractable covers are beingretracted.

According to a further feature of the present invention, said firstretractable cover and said second retractable cover are being designedto be retracted to different directions.

According to a further feature of the present invention, said first sideregion has a retractable cover fixating slot adjacent to said non-linearslot in said first sheet, the length of said retractable cover fixatingslot being compatible with the width of said second retractable cover.

According to a further feature of the present invention, the edges ofthe perforated region being connected to the soft tissue blocking regionto form a bag, a bone augmenting material being inside the bag.

According to a further feature of the present invention, the perforatedregion has more than 10 holes.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, pores which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, pores which arelarger than 5 microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least partof the sheet is a guided regeneration membrane.

According to a further feature of the present invention, at least partof the sheet is a pericardium membrane.

According to a further feature of the present invention, at least partof the sheet is a collagen membrane.

According to a further feature of the present invention, at least partof the sheet is a synthetic membrane.

According to a further feature of the present invention, the first sideregion is connected to the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by an adhesive layerlocated between the first side region and the second side region.

According to a further feature of the present invention, the first sideregion is connected to the second side region by sutures.

According to a further feature of the present invention, the first sideregion is connected to the second side region by heat and/or pressure.

According to a further feature of the present invention, the first sideregion is connected to the second side region in a non-continues mannerso as to have non connected areas of the side regions between connectedareas of the side regions.

According to a further feature of the present invention, the first sideregion has a slot and the second side region has a connecting extension,part of the connecting extension of the second side region having awidth which is larger than the length of the slot in the first sideregion.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slot in the first side region.

According to a further feature of the present invention, the first sideregion has two adjacent slots and the second side region has aconnecting extension, part of the connecting extension of the secondside region having a width which is larger than the length of the slotsin the first side region.

According to a further feature of the present invention, the part of theconnecting extension of the second side region being inserted throughthe slots of the first side region.

According to a further feature of the present invention, the second sideregion has a slot and the first side region has a connecting extension,part of the connecting extension of the first side region having a widthwhich is larger than the length of the slot in the second side region.

According to a further feature of the present invention, the part of theconnecting extension of the first side region being inserted through theslot in the second side region.

According to a further feature of the present invention, one edge of theperforated region being connected to the soft tissue blocking region toform a bag having a filling opening adjacent the opposite edge of theperforated region.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the holes in the perforated regionto form a bag.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed between the first side region and the second side region toform a bag.

According to a further feature of the present invention, a boneaugmenting material is located between the perforated region and thesoft tissue blocking region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are larger than the diameter of the holes inthe perforated region.

According to a further feature of the present invention, a particulatedbone augmenting material is located between the perforated region andthe soft tissue blocking region, the diameter of the particles of thebone augmenting material are smaller than the diameter of the holes inthe perforated region and the particles are in a flowable material.

According to a further feature of the present invention, the edges ofthe perforated region being connected to the tissue blocking region toform a bag, a bone augmenting material being inside the bag.

Thus, according to the teachings of the present invention there isprovided a method for treating patients in need for tissue regenerationin the lower jaw comprising:

-   -   a. detaching the lingual periosteal tissue from a lingual        surface of the lower jaw bone to form a lingual opening between        the lingual periosteal tissue and the lingual surface of the        lower jaw bone;    -   b. forming a subperiosteal tunnel through the lingual opening,        the subperiosteal tunnel extends from the lingual opening along        a segment of the lower jaw bone and a segment of a periosteal        tissue;    -   c. inserting through the lingual opening a bag inside the        subperiosteal tunnel, the bag has a perforated region having        holes which are larger than 30 microns, the bag has a soft        tissue blocking region in which holes which are larger than 20        microns are absent, the bag contain a bone augmenting material,        the perforated region of the bag being placed towards at least        part of the segment of the lower jaw bone, the soft tissue        blocking region being placed towards at least part of the        segment of the periosteal tissue.    -   d. closing the lingual opening and leaving the bag adjacent the        segment of the lower jaw bone for at least several days to allow        bone tissue ingrowth through the holes inside the bag.

According to a further feature of the present invention, the soft tissueblocking region has a at least one retractable cover that when beingretracted forms an opening to allow filling of the bag.

According to a further feature of the present invention, the segment ofthe periosteal tissue being located distally to the lingual opening.

According to a further feature of the present invention, the segment ofthe periosteal tissue being located mesially to the lingual opening.

According to a further feature of the present invention, an additionalbone augmenting being inserted inside the subperiosteal tunnel adjacentto the bag.

According to a further feature of the present invention, an additionalbone augmenting being inserted inside the subperiosteal tunnel betweenthe bag and the segment of the lower jaw.

According to a further feature of the present invention, an opening tothe subperiosteal tunnel is being formed also in the buccal aspect ofthe lower.

According to a further feature of the present invention, the lingualopening being enlarged to reach the buccal aspect of the lower jaw.

According to a further feature of the present invention, thesubperiosteal tunnel extends along an occlusal aspect of the segment ofthe lower jaw.

According to a further feature of the present invention, thesubperiosteal tunnel extends along a buccal aspect of the segment of thelower jaw.

According to a further feature of the present invention, the bag beingplaced along a buccal aspect of the segment of the lower jaw.

According to a further feature of the present invention, the bag beingplaced along an occlusal aspect of the segment of the lower jaw.

According to a further feature of the present invention, the bag beingplaced along a lingual aspect of the segment of the lower jaw.

According to a further feature of the present invention, the bag beingfixated to the lower jaw using a bone tack.

According to a further feature of the present invention, the bag beingfixated to the lower jaw using a screw.

According to a further feature of the present invention, the bag beingfixated to the lower jaw using a glue.

According to a further feature of the present invention, the bag beingfixated to the periosteal tissue using a suture.

According to a further feature of the present invention, the bag beingfixated to the periosteal tissue using a glue.

According to a further feature of the present invention, the bag beingfilled using a syringe having the bone augmenting material.

According to a further feature of the present invention, the perforatedregion has more than 10 holes.

According to a further feature of the present invention, the holeshaving diameter of more than 100 microns.

According to a further feature of the present invention, the holeshaving diameter of 500 microns-3000 microns.

According to a further feature of the present invention, the holeshaving diameter of 800 microns-2500 microns.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, the holesoccupy more than percent of the perforated region.

According to a further feature of the present invention, holes which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, holes which arelarger than microns are absent from the soft tissue blocking region.

According to a further feature of the present invention, at least partof the soft tissue blocking region is made from a guided regenerationmembrane.

According to a further feature of the present invention, at least partof the soft tissue blocking region is made from pericardium membrane.

According to a further feature of the present invention, at least partthe soft tissue blocking region is made from collagen membrane.

According to a further feature of the present invention, at least partthe soft tissue blocking region is made from synthetic membrane.

According to a further feature of the present invention, at least partthe soft tissue blocking region has a first sheet and a second sheetabove the first sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by an adhesive layer located betweenthe first sheet and the second sheet.

According to a further feature of the present invention, the first sheetis connected to the second sheet by sutures.

According to a further feature of the present invention, the first sheetis connected to the second sheet by heat and/or pressure.

According to a further feature of the present invention, the first sheetis connected to the second sheet in a non-continues manner so as to havenon connected areas of the sheets between connected areas of the sheets.

According to a further feature of the present invention, the first sheethas a slot and the second sheet has a connecting extension, part of theconnecting extension of the second sheet having a width which is largerthan the length of the slot in the first sheet.

According to a further feature of the present invention, the part of theconnecting extension of the second sheet being inserted through the slotin the first sheet.

According to a further feature of the present invention, the first sheethas two adjacent slots and the second sheet has a connecting extension,part of the connecting extension of the second sheet having a widthwhich is larger than the length of the slots in the first sheet.

According to a further feature of the present invention, the part of theconnecting extension of the second sheet being inserted through theslots of the first sheet.

According to a further feature of the present invention, the secondsheet has a slot and the first sheet has a connecting extension, part ofthe connecting extension of the first sheet having a width which islarger than the length of the slot in the second sheet.

According to a further feature of the present invention, the part of theconnecting extension of the first sheet being inserted through the slotin the second sheet.

According to a further feature of the present invention, one edge of theperforated region being connected to the soft tissue blocking region toform the bag having a filling opening adjacent the opposite edge of theperforated region.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed above at least part of the holes in the perforated regionto form the bag.

According to a further feature of the present invention, the perforatedregion includes an edge closing extension, the edge closing extensionbeing placed between the first sheet and the second sheet to form thebag.

According to a further feature of the present invention, the boneaugmenting material includes a particulated bone augmenting material,the diameter of the particles of the bone augmenting material are largerthan the diameter of the holes in the perforated region.

According to a further feature of the present invention, the boneaugmenting material includes a particulated bone augmenting material,the diameter of the particles of the bone augmenting material aresmaller than the diameter of the holes in the perforated region and theparticles are in a flowable material.

According to a further feature of the present invention, the edges ofthe perforated region being connected to the tissue blocking region toform the bag.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1 is a perspective view illustrating an embodiment of a sheethaving a perforated region.

FIG. 2 is a perspective view illustrating an embodiment of a tube formedafter folding and/or rolling the sheet of FIG. 1 .

FIG. 3 is a perspective view illustrating an embodiment of a bag formedafter closing one edge of the tube of FIG. 2 while the other edge isopen.

FIG. 4 is a perspective view illustrating an embodiment of the bag ofFIG. 3 after the bag being filled and the other edge of the bag beingclosed.

FIG. 5 is a perspective view illustrating an embodiment of a sheethaving a perforated region and edge closing extension to allow easyclosure of the edge of the tube, formed after folding and/or rolling thesheet.

FIG. 6 is a perspective view illustrating an embodiment of a sheethaving a perforated region, edge closing extension to allow easy closureof the edge of the tube formed after folding and/or rolling the sheet,connecting extensions and a slot for each connecting extension toconnect the two side regions of the sheet.

FIG. 7 is a perspective view illustrating an embodiment of a sheethaving a perforated region, edge closing extension to allow easy closureof the edge of the tube, formed after folding and/or rolling the sheet,connecting extensions and two slots for each connecting extension toconnect the two side regions of the sheet.

FIG. 8 is a perspective view illustrating an embodiment of a bag formedafter folding and/or rolling the sheet of FIG. 7 , closing one edge withthe edge closing extension and connecting the side regions of the sheetusing the connecting extensions inserted through the two slots.

FIG. 9 is a perspective view illustrating an embodiment of a bag havingone edge closed and a second edge closing extension to allow easyclosure of the second edge of the bag after filling the bag.

FIG. 10 is a perspective view illustrating the mandible in which theanterior lingual mucoperiosteal tissue was detached from the jaw bone tocreate a lingual opening to a subperiosteal tunnel.

FIG. 11 is a perspective view illustrating the mandible of FIG. 10 inwhich a bag is inserted through the anterior lingual opening inside thesubperiosteal tunnel towards the posterior region of the jaw bone.

FIG. 12 is a lateral view illustrating fixating the bag inside themaxillary sinus during an open sinus lift procedure, while using suturesand/or wires and additional fixating holes.

FIG. 13 is a perspective view illustrating an embodiment of a sheethaving a perforated region, closing extensions and retractable covers tocover a side opening.

FIG. 14 is a perspective view illustrating an embodiment of a bag formedafter folding and/or rolling the sheet of FIG. 13 . The bag has a sideopening and an edge opening to allow filling of the bag.

FIG. 15 is a perspective view illustrating an embodiment of the bag ofFIG. 14 after the bag being filled and the edge opening closed and theside opening being covered by the two retractable covers.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before turning to the features of the present invention in more detail,it will be useful to clarify certain terminology as will be used hereinin the description and claims. Specifically, it should be noted that thepresent invention is useful in a wide range of applications in whichliving tissue is to be regenerated or treated. The term “living tissue”is used herein to refer to any living tissue including, but not limitedto bone, an organ, tube, vessel, cavity, bone cavity or membrane, andinterfaces between any two or more of the above. Where used within asingle type of tissue, the typical application of the present inventionis for regenerating the tissue inside the tissue. When used at a tissueinterface, the invention is typically used to separate between tissuesand/or treating only one tissue.

It is noted that a large number of different types of materials areknown which may be inserted within the body during a surgical procedureand which later dissipate, thereby avoiding the need for a separatesurgical procedure for their removal. Such materials are properlyreferred to, depending upon the mechanism by which the materialdissipates, as “resobable”, “bioresorbable”, “absorbable”,“bioabsorbable”, “degradable” or “biodegradable”. Despite thedifferences between these different classes of materials, theaforementioned terminology is widely used interchangeably by medicalprofessionals. Accordingly, and for conciseness of presentation, onlyone of these terms will generally be used in the following description,without implying the exclusion of the other classes of materials.Additionally, the phrase “bio-dissipative material” is used herein inthe description and claims to refer generically to any and all materialswhich dissipate without requiring surgical removal, independent of whichmechanisms such as dissolution, degradation, absorption and excretiontake place. The actual choice of which type of materials to use mayreadily be made by one ordinarily skilled in the art.

The bone can be regenerated by several biological mechanisms:Osteogenesis in which the bone augmenting material includes bone formingcells; Osteoinduction in which the bone augmenting material includesmaterials that induce cells to form bone or to differentiate to becomebone forming cells; Osteoconduction in which the bone augmentingmaterial provides a scaffold for bone forming cells; or Osteopromotionin which encouraging the biologic or mechanical environment of boneregeneration. The bone augmenting material can be an autograft, anallograft, a xenograft, an alloplast, a cytokine, a hormone, a growthfactor, a physiologically acceptable drug, a biological modifier, aprotein (for example B one Morphogenetic Protein (like BMP-2, BMP-7)),an antigen, a cell chemotaxis stimulator material, a material inducingosteogenesis, an osteoinduction material, an osteoconduction material, abioactive material, a bioresorbable material, a bioabsorbable material,a bio-dissipative material and any combination thereof. The boneaugmenting material can include materials that occupy a space in thebody for at least several weeks. These materials preferably encouragethe tissue to grow inside the space occupied by the material. This isthe principle function of most bone augmenting materials available onthe market. The bone augmenting material can be entirelybio-dissipative. The bone augmenting material can be available in themarket like hydroxyapatite, bovine mi neral (i.e. Bio-Oss available fromGeistlich, Switzerland), materials from other species, for example,equine origin materials, materials combining mineral and collagen (i.e.OX granules available from Bioteck SPA, Italy), demineralized frizzeddried bone allograft, synthetic materials like PLA or suspension of mineral particles (from various origins) in a liquid medium. The boneaugmenting material can be also fully or partially not bio-dissipative,for example crystal hydroxyapatite. The bone augmenting material caninclude therapeutic materials.

The bone augmenting material can be a biocompatible filing material thatsets and becomes rigid inside the tissue. The biocompatible fillingmaterial can be a bio-dissipative material that contains materialsassisting in the process of bone healing like bone cements, for exampleSkeletal Repair System (SRS) from Norian company, Healos from Orquestcompany, OsteoGenics and Orthovita's Orthocomp from Howmedical Leibingercompany.

Most bone augmenting materials are available as particles in the size of200-2000 microns. To allow easy insertion, preferably the particles aremixed with a solution like saline, blood or biocompatible gels likecellulose, glycerol and/or hydrogel. The bone augmenting material can behigh viscous gel like Dinagraft which is gelatinous allograft boneaugmenting material and/or with bone cements calcium sulfate and/orcalcium carbonate. Additionally, the phrase “augmenting material” isused herein in the description and claims to refer generically to anyand all these materials and mechanisms and in all mediums and/or gels inwhich these materials are mixed with. The actual choice of which type ofmaterials and/or combination of materials to use may readily be made byone ordinarily skilled in the art.

Along the description sometimes the device is called “bag” and sometimes“container”. Both terms refer to a device that can contain boneaugmenting material. The “container” or “bag” can be also a pouch orcloth like pouch in all the embodiments.

The term “anterior” means more towards the front and close to the lips.The term “posterior” mean more towards the back and close to the throat.The term “buccal” means the side towards the cheeks and lips. The term“lingual” means the side towards the tongue. The term “mesial” insidethe mouth means in dentistry towards the location of central teeth alongthe dental arch. The term “distal” inside the mouth means in dentistrytowards the location of posterior teeth along the dental arch.

The term membrane means a sheet of material that can be made fromvariable materials in variable shapes and any combination of materials.The membrane preferably can be made from biocompatible materials. Themembrane can be partially or completely bio-dissipative or can becompletely non resorbable. The membrane can be made from artificialmaterials, for example polyglycolic acid (PGA) mesh, ahigh-molecular-weight linear polymer made by the ring openingpolymerization of the purified glycolide monomer, e.g. polyglactin 910,i.e. polyglycolide co-galactide or/and PDS (another absorbable suturematerial) and/or cellulose which are bio-disipative or can be made fromPTFE and/or ePTFE and/or Teflon which are not resorbable. The membranecan be made from autograft, allograft, xenograft and any combinationthereof. For example the membrane can be made from collagen and/orcross-linked collagen. The membrane can be made from pericardium,peritoneum, vessels and other tissues and/or biological membranes. Themembrane can have different thickness at different regions of themembrane. The membrane can have different stiffness and/or flexibilityat different regions of the membrane. The membrane can have more thanone layer and each layer can have different properties and/or can bemade from different materials. The membrane can include a guided tissueregeneration membrane and/or guided bone regeneration membrane. Guidedbone regeneration (GBR) membranes are used in dental implant dentistryto regenerate bone. The GBR membranes prevent the epithelial andconnective tissue to penetrate the bone defect and interfere with thebone regeneration process. The membrane can be any combination of theabove.

When the bag is inserted inside a subperiosteal tunnel, there is anadvantage to using a tear resistant membrane like a pericardiummembrane, for example Jason membrane from Botiss (Germany) or likecompressed collagen, for example Bio-Gide compress from Geistlich(Switzerland).

A long the description sometimes the device and/or part of it is called“sheet” and sometimes “membrane”. Both terms refer to a device and/orpart of the device which can be used to form a bag. The sheet ormembrane is usually flexible like a cloth or a fabric. The sheet ormembrane can be cloth like ready to use or might requires hydration tobecome less stiff and more flexible like a fabric.

A long the description holes and/or perforations are mentioned havingdifferent optional diameters. The use of the term “diameter” doesn'tnecessarily imply that the shape of the holes is round. The holes canhave various shapes like ellipse and/or polygonal shapes for examplesquare or hexagon and can have a non-regular or non-defined shape.

The term mucoperiosteal tissue in the jaws can mean also gums and/orgingiva.

Finally with respect to terminology, reference will be made to aflowable material that can be used to fill the containers and/or bags ofthe present invention. It should be noted that this flowable materialmay assume a wide range of compositions and consistencies, so long asthe filling material may be inserted into the container. Thus, possibleconsistencies for the filling material include, but are not limited to,consistencies described as watery, viscous, gelatinous, moldable, waxen,particulate, and suspensions or mixtures combining any of the above. Thefilling material can be also any kind of a bone augmenting materialdescribed above, which can be a flowable material. The bone augmentingmaterial can be a suspension of particles is a solution like saline. Thebone augmenting material can be particles inside gel. The particles canbe from any type of bone augmenting material motioned above and the gelcan be from any type of bone augmenting material mentioned above. Thegel can include collagen and/or any material encouraging bone formation.

Turning now in detail to the drawings, which depict the presentlypreferred embodiments of the invention for the purpose of illustratingthe practice thereof and not by way of limitation of the scope of theinvention, and in which like reference characters refer to correspondingelements throughout the several views.

FIG. 1 , illustrates a sheet of a membrane 10 (hereafter called sheetand/or membrane) having a middle region 11 (between the dotted lines inFIG. 1 ) which can be perforated with several holes 12 and two sideregions 13, 14 on each side of the middle region. The middle region 11doesn't have to be at the middle of the sheet. The side regions 13, 14can be not perforated. The side regions can include perforations with adiameter up to 5 microns and/or up to 10 microns and/or up to 15 micronsand/or up to 20 microns and/or up to 25 microns and/or up to 30 micronsso the diameter of largest hole in the side regions 13, 14 can be 5microns or 10 microns or 15 microns or 20 microns or 25 microns or 30microns. The side regions 13, 14 and the middle region 11 can haveseveral types of holes with different dimensions and different shapes.The sheet 10 can be folded and/or rolled so a first side region 13 canbe placed over the middle region 11 and a second side region 14 can beplaced over the first side region 13. This folding and/or rolling of thesheet membrane 10 can create a tube like structure 20 as illustrated inFIG. 2 . The tube like structure 20 can have a middle perforated region11 on one side of the tube 20 and two layers of membrane 13, 14 (thefirst and second side regions) on the other side of the tube forming asoft tissue blocking region 21 of the tube 20.

The folding can be along the folding lines 15. The folding can beassisted by placing a stick having a width like the width of the middleregion, between the folding lines 15. The stick can be place on themiddle region 11 and the side regions 13, 14 folded on the stick. Thefolding line 15 can include perforations and/or small slots havinglength of 0.5-3 mm or 1-2 mm or more than 3 mm. The folding lines 15 caninclude places having thinner width, like an imprint and/or an embossingin the membrane 11 along the folding lines 15 having length of 0.5-3 mmor 1-2 mm or more than 3 mm. These slots or embossing will enable easyfolding of the membrane 11 along the folding lines 15.

The second side region 14 can be connected to the first side region 13and/or to the middle region 11 so the tube 20 keeps its tube structureand to prevent unfolding of the sheet membrane 10. The connectionbetween the regions can be for example by suturing and/or gluing withbiocompatible sutures/glues. The connection between the regions can bealso by pressure and/or heat.

The tube doesn't have to be oval and can have any other morphology.

The glue mentioned above and later can be a polymer and/or hydrogelwhich polymerize under radiation during the sterilization process asdescribed in international application No. WO 2015/107502 to BioteckS.P.A., the entire disclosure of which is hereby incorporated byreference.

The glue can be a flexible glue to keep the bag flexible so it willeasily adapt to the bone morphology. The glue can be placed withintervals and/or only in several points so as to keep the flexibility ofthe bag.

The tube 20 can be closed at one edge 31 of the tube to form a container30 as illustrated in FIG. 3 . The closing can be for example by suturingand/or gluing with biocompatible sutures/glues. The closing of the tubeedge 31 can be also by pressure and/or heat. It is possible to foldand/or roll the tube edge 31 before closing or to close it withoutfolding and/or rolling.

The device can be marketed to the surgeon as a sheet membrane 10, likethe membrane illustrated in FIG. 1 with the middle region that can beperforated and the side regions 13, 14, and the surgeon will fold and/orroll and connect the side regions 13, 14 to form the tube 20 asillustrated in FIG. 2 . Then the surgeon can close one edge 31 of thetube to form the container 30 like the container illustrated in FIG. 3 .

The device can be marketed to the surgeon as a tube 20, like the tubeillustrated in FIG. 2 . Then the surgeon can close one edge 31 to formthe container 30 like the container illustrated in FIG. 3 .

The device can be marketed to the surgeon already as a container 30,like the container illustrated in FIG. 3 .

The container 30 can be filled with bone augmenting material. It can befilled with several bone augmenting materials, having differentproperties and with any combination of bone augmenting materials and/orany combination of a bone augmenting material and other materials likefor example carriers, gels, polymers and hydrogels. The container 30 canbe filled for example with a slow resorbable and/or a non-resorbablebone augmenting material together with a fast resorbable material. Thecontainer can be filled for example with small particle of boneaugmenting material having for example size of less than 200 micronsand/or size of 200-600 microns and/or size of 500-1000 microns. Thecontainer can be filled in addition or only, for example, with largeparticle bone augmenting material having for example size of more than600 microns and/or size of 1000-2000 microns and/or size of more than2000 microns. The container can be filled for example with particles andgels.

The middle perforated region can have holes 12 which are large enough toallow bone tissue growth through these holes. The diameter of the holescan be larger than 10 microns preferably larger than 50 microns and/orlarger than 100 microns and/or larger than 500 microns and/or largerthan 1000 microns. The larger the holes the faster the boneregeneration. The diameter of the holes can be 500-2000 microns and/or1000-1800 microns or larger than 2000 microns.

The holes 12 can be circular or to have any other shape. The holes 12can occupy at least 30 percent of the surface of the middle perforatedregion 11. Preferably the holes 12 occupy at least 50 percent of thesurface of the middle perforated region 11 and/or at least 70 percent ofthe surface of the middle perforated region 11 and/or at least 90percent of the of the surface of the middle perforated region.

The middle region can have 2-10 holes and/or 10-20 holes and/or 20-50holes and/or 50-70 holes and/or 70-100 holes and/or 100-130 holes and/ormore than 130 holes. The number of holes can be determined according tothe size of the middle region. The middle region can have 2-5 holes percm 2 and/or 5-10 holes per cm 2 and/or 1-15 holes per cm 2 and/or 15-20holes per cm 2 and/or 20-25 holes per cm 2 and/or more than 25 holes percm 2.

The middle perforated region 11 can have holes 12 which are sizedaccording to the bone augmenting material. For example, according to thesize of the particles of the bone augmenting material and/or accordingto the viscosity and/or fluidity of the bone augmenting material. Thediameter of the holes 12 can be less than the diameter of part of theparticles of the bone augmenting material and/or less than the diameterof the majority of the particles of the bone augmenting material and/orless than the diameter of all the particles of the bone augmentingmaterial.

The holes 12 can be larger than the diameter of the bone augmentingparticles. In another embodiment the holes 12 can be larger than thediameter of the bone augmenting particles while the bone augmentingparticles are inside a flowable surrounding, for example saline and/or amaterial that includes saline and/or blood and/or gel and/or collagen.

The filling of the container 30 can be done by pouring the boneaugmenting material inside the container and/or using a spoon likedevice and/or using a syringe, a rigid tube, a funnel, a stick and/orany other device that can be inserted inside the container 30.

After the container 30 is filled with the appropriate amount of boneaugmenting material, the container 30 can be closed at the second edge41 of the container (the container's opening through which the boneaugmenting was filled) to form a closed container 40 as illustrated inFIG. 4 . The closing can be for example by suturing and/or gluing withbiocompatible sutures/glues. The closing of the container's opening canbe also by pressure and/or heat. It is possible to fold and/or roll thecontainer edge 41 before closing or to close it without folding and/orrolling.

The container 40 can be marketed already filled with the bone augmentingmaterial as illustrated in FIG. 4 or to be marketed as an open container30 as illustrated in FIG. 3 to be filled with bone augmenting materialand close by the surgeon.

The sheet and/or membrane 10 can include an edge closing extension 51adjacent the middle/perforated region as illustrated in FIG. 5 . Thisedge closing extension 51 can be used to enable easy closure of one sideof the container. The sheet and/or membrane 10 can be folded and/orrolled so the first side region 13 can be placed over the middle region11, then the edge closing extension 51 can be folded and/or rolled andplaced over the first side region 13, then the second side region 14 canbe placed over the first side region 13 and the edge closing extension51. T his folding and/or rolling of the sheet and/or membrane and theedge closing extension 51 can create a container 30 as illustrated inFIG. 3 . The container 30 having the middle/perforated region 11 on oneside of the container and two layers of membrane (the first and secondside regions 13, 14) along at least part of the other side of thecontainer forming the soft tissue blocking region 21. Adjacent the edgeclosing extension 51 there are three layers of membrane (the first andsecond side regions 13, 14 and the edge closing extension 51) along partof the soft tissue blocking region.

It is also possible that the edge closing extension 51 is folded overthe middle perforated region, and the first and second side regions 13,14 are placed over the edge closing extension 51. It is also possiblethat the edge closing extension 51 is folded over the first and secondside regions 13, 14. The sequence and order of placing the variouselements of the membrane 10 one on top of the other can be changedaccording to manufacturing preferences. However, if the closingextension 51 is short, it will be easier to stabilize the bag 30 whilethe closing extension 51 is between the side regions 13, 14.

The membrane 10 can have along at least part of its borders connectingextensions 61 as illustrated in FIG. 6 having connecting extensions 61extending form one side region 13. The connecting extensions 61 can havea constant width or have an arrow shape or any other shape in which thewidth of the connecting extension 61 is not constant. The connectingextensions 61 can have a neck portion 62 and an anchoring portion 63which is wider than the neck portion 62. The neck portion 62 of theconnecting extension 61 being closer to the center of the membrane 10.The membrane 10 can have slots 64 so at least part of the connectingextensions 61 can be inserted through the slots 64. The length of theslots 64 can be compatible with the width of the neck portion 62 andless than the width of the anchoring portion 63 of the connectingextension 61, so after the insertion of the anchoring portion 63 throughthe slot 64, the anchoring portion 63 resist passing back through theslot 64 without being folded. The slots 64 can be along the foldinglines 15 so as to assist also with the folding of the membrane 10. Theslots 64 can be also displaced from the folding lines 15.

The membrane can have two adjacent slots 64, 65 as illustrated in FIG. 7so when the connecting extension 61 is passed through both adjacentslots 64, 65 the anchoring portion 63 will be outside the container 80as illustrated in FIG. 8 .

The closing extension 51 can have also a slot 66 or two slots 66, 67that can be, after folding, above the slots 64, 65 in the side region 14so the connecting extension 61 can pass through the slots 64, 65 in theside region 14 and also through the slots 66, 67 in the closingextension 51, to better stabilize the bag.

The length of the connecting extension 61 can be 1-20 mm or 2-10 mm or3-7 mm. The membrane 10 can have more than one connecting extension or2-10 or 3-7 connecting extensions. The distance between the connectingextensions 61 can be 2-25 mm or 3-15 mm or 5-10 mm. The connectingextensions 61 can be along both side regions 13, 14 and both sideregions 13, 14 can have slots 64, 65 so each side region can beconnected to the other side region. Slots can be at the middle region 11and can be on both sides of the middle region 11.

The edge closing extension 51 can have one or more connecting extensions61 and the first side region 13 and/or the second side region 14 canhave one or more slots to fixate the edge closing extension 51 to atleast one of the side region (13, 14) in a similar manner as the firstside region 13 being connected to the second side region 14.

The second side region 14 can be connected to the first side region 13and/or to the middle region 11 and/or the edge closing extension 51, sothe container 80 keeps its structure and to prevent unfolding of themembrane 10. The connection between the regions of the membrane 10 canbe in any manner.

The container 90 can have a second edge closing extension 91 adjacentthe opening of the container 92 as illustrated in FIG. 9 to allow easyclosure of the opening 92 of the container 90 after filling thecontainer 90 with the bone augmenting material. The second edge closingextension 91 can be folded and/or rolled inside the container 90 orabove the second side region 14 or between the first side region 13 andthe second side region 14.

The membrane 10, the regions of the membrane 11, 13, 14, 51, 91, theconnecting extensions 61 and the container 90 can have variable sizesand shapes, according to the bone deficiency needs to be regenerated.The membrane 10 can be for example rectangular with length of more than60 mm or 40-60 mm or 20-40 mm or 4-20 mm or 5-17 mm and width of morethan 60 mm or 40-60 mm or 20-40 mm or 4-20 mm or 5-17 mm and anycombination of length and width. The container can have length of morethan 60 mm or 40-mm or 20-40 mm or 4-20 mm or 5-17 mm. The width of thecontainer can be more than mm or 40-60 mm or 20-40 mm or 4-20 mm or 5-17mm. The length of the container for regenerating a region of about 3missing teeth can be 20-45 mm and the width of the container can be 7-20mm. The length of the container for regenerating a region of about 1missing teeth can be 5-15 mm and the width of the container can be 7-20mm.

The closing extensions 51, 91 can have several shapes and severaldimensions. The length of the closing extensions 51, 91 (along a lineconnecting the openings of the tube) can be 3-20 mm or 5-18 mm, or 10-15mm or 7-10 mm or longer than 20 mm. The width of the closing extensions51, 91 can be the same as the width of the middle region 11 or can bewider or narrower by 0.5-4 mm or 1-3 mm than the width of the middleregion 11. The closing extensions can have a rectangular shape and/orhave rounded corners and/or any other shape.

The middle region 11 and the side regions 13, 14 can have variableportions along the membrane 10. The middle region 11 and the sideregions 13, 14 can be a third of the width of the membrane 10. Themiddle region 11 can be narrower than the side regions 13, 14. The sideregions 13, 14 can have substantially the same width or one side regioncan have larger width than the other side region. The second side regioncan cover completely the first side region or can cover only part of thefirst side region. The first side region can cover completely the middleregion or can cover only part of the middle region. The second sideregion can cover completely the middle region or can cover only part ofthe middle region. The width of the middle region 11 can be larger than20 mm or 3-25 mm or 5-20 mm or 7-16 mm.

The middle region 11 can be perforated with several holes 12. The holes12 can be along only part of the middle region 11. The edges of themiddle region 11 along its width, towards the closing extension s 51,91, can be without holes for 1-10 mm or 3-7 mm or 1-3 mm. The edges ofthe middle region 11 along its length, towards the first and/or secondside regions 13, 14, can be without holes for 1-10 mm or 3-7 mm or 1-3mm.

The middle region 11 can be without holes and to be bio-dissipative. Themiddle region 11 can bio-dissipate faster than the side regions 13, 14,which can be also non bio-dissipative. The middle region 11 can bebio-dissipative and/or to have holes. Any combination of degree ofbio-dissipatedness and perforations can be.

The holes can have various combinations of sizes. For example, themiddle region can have combination of large holes of more than 1000microns with small holes of less than 500 microns.

The bone augmenting material can have various combinations of sizes. Forexample, the bone augmenting can have combination of large particles ofmore than 1000 microns with small particles of less than 500 microns.The combination of bone particles can be used with a container having acompatible combination of holes' sizes.

The bone augmenting material can have at least two bone augmentingmaterials having different times of resorption. For example, a fastbio-dissipative material that will allow fast ingrowth of blood vesselsand bone forming cells and a slowly bio-dissipative and/or nonresorbable bone augmenting material that will keep the volume for a longperiod of time. The slowly bio-dissipative material can be for example abovine mineral (like Bio-Oss from Geistlich, Switezerland) that remainsin the body for several years.

A slowly bio-dissipative material can be used for example also foraesthetic treatments without bone regeneration or together with boneregeneration. A container filled with slowly bio-dissipative materialcan be placed along the buccal aspect of the anterior maxillary alveolarridge to increase the volume of the tissue and advance the position ofthe upper lip. This advance of the upper lip can eliminate wrinkles andimprove the aesthetic smile and appearance. A container filled withslowly bio-dissipative material can be placed for example adjacent thezigomatic bone to advance the cheek bones. The exact position of thecontainer can be decided for each patient according to its individualneeds and according to the individual deficiency that needs to befilled.

The surgeon can prepare and insert the container through a subperiostealtunnel or to raise a mucoperiosteal flap and suture the mucoperiostealflap over the container. The middle region can be placed towards thebone and the side regions towards the periosteal tissue. The jaw bonecan be perforated before the placement of the container adjacent the jawbone.

In the lower jaw the preparation of the subperiosteal tunnel and/or theinsertion of the container inside the tunnel can damage the mental nerveand/or its branches which are located on the buccal side of lower jaw.

In a novel method of using the container (or bag or pouch), at leastpart of the subperiosteal tunnel is prepared from the lingual side ofthe lower jaw as illustrated in FIGS. 10 and 11 . The opening of thetunnel can be from the lingual side of the mandible (the lower jaw) 100and in many cases from the anterior lingual side. The lingual opening102 can be done by raising a lingual mucoperiosteal flap 101 below theanterior teeth 103 as illustrated in FIG. 10 . The lingual opening 102can be along any segment of the lingual aspect of the mandible 100 andto cross the midline of the mandible. The insertion of the container 110can be through the lingual opening 102 as illustrated in FIG. 11 . Inthis manner the mental nerve is not damaged. After the insertion of thecontainer 110 it can be placed on top of the alveolar ridge tovertically augment the lower alveolar ridge and/or to be inserted andplaced at the buccal and/or lingual aspects of the lower jaw bone tohorizontally augment the alveolar ridge. To reach the buccal aspect, thecontainer 110 can be pushed from the lingual side over the alveolarcrest and down to the buccal side.

Before the insertion of the container 110 into the subperiosteal tunnel,it is possible to connect to the container a suture 111, which isconnected to a needle 112, and to insert the needle 112 and the suture111 inside the tunnel and to pass the needle 112 and the suture 111through the periosteal tissue to be outside the tunnel as illustrated inFIG. 11 . This way it is possible to pull the suture 111 and assist inthe insertion and placement of the container inside the tunnel. Thesuture 111 can be sutured to the soft tissue so as to fixate thecontainer, which is inside the tunnel. The suture 111 can be made from abio-dissipative material.

The lingual opening 102 can be at the lingual anterior region of thelower jaw 100 and the container being placed at the posterior region ofthe lower jaw as illustrated in FIG. 11 . The lingual opening can be atthe lingual posterior region of the lower jaw and the container beingplaced at the anterior region of the lower jaw. The location of thelingual opening and the location of the container can be determinedindividually for each patient. There are advantages if the lingualopening is not above the location of the container, because if there isa later opening of the sutures at the lingual opening, it is not abovethe container and the chances for infection of the container arereduced. There are also advantages that the periosteal tissue above thecontainer is not cut and sutured so the blood supply to the tissue isnot damaged and therefore reducing the chances for exposure of thecontainer.

The container (or bag or pouch) can be inserted inside the tunnel whilebeing inside a dedicated syringe and then injecting the container to itsplace. This way the membrane of the container is not touching thesurrounding tissues during the insertion of the container and themembrane of the container is not damaged. In another embodiment thecontainer is inserted inside a cover and/or an envelope and/or a sleevebefore being inserted inside the tunnel and after the insertion of thecontainer the cover and/or the envelope and/or the sleeve is removedleaving the container inside the tunnel. This way the membrane of thecontainer is not touching the surrounding tissues during the insertionof the container and the membrane of the container is not damaged. Thecover and/or envelope and/or sleeve can be closed at one side to form abag like cover with one opening. If the container is connected to asuture 111, then the suture exit the cover from the open side of thecover while the closed side of the cover is at the opposite side. In theembodiment of FIGS. 10 and 11 the closed side of the cover will betowards the anterior of the mandible. The cover can be flexible and canbe made, for example, from rubber, nylon, silicon and any othermaterials and combinations thereof. It will be advantageous if the coverwill be transparent so the surgeon will know where the perforated sideof the container is. It will be advantageous if the cover bag will bemade from biocompatible materials.

The container can be also fixated using a bone screw like a GBR membranefixating screw and/or fixated by a tack or a pin like a GBR membranefixating tack (for example, titan pin set from Botiss, Germany). Thefixating inside the tunnel can be by using a curved tack delivery device(for example the AutoTac membrane fixation kit from BioHorizons U.S.).The bag can have an extension for fixation through which the bone screwand/or the bone tack will be inserted. The extension for fixation can beperforated to enable the surgeon to see the bone while inserting thescrew and/or the tack. The perforated extension for fixation can be partof the perforated middle region 11 of the sheet 10 illustrated in FIGS.1, 5, 6 and 7 after the preparing a bag, which is shorter than theperforated middle region.

The container can be stabilized by more than one tack or screw. Forexample, it is possible to use two tacks at the side of the bag which isclose to the opening of the subperiosteal tunnel. For example, in theembodiment of FIGS. 10 and 11 , the anterior (or mesial) side of thecontainer can be fixated with one tack adjacent the anterior buccalcorner of the container and a second tack adjacent the anterior lingualcorner of the container. By using more than one tack (or screw) therotation of the bag is prevented and the stabilization is improved.

It is also possible to insert through the gums at the posterior (ordistal) region a fixating screw and/or a tack and/or a pin to stabilizethe posterior region of the container. It is possible to perform a smallcut in the posterior region of gums before the insertion of the fixatingscrew and/or the tack to enable the surgeon to see the container beforeinserting the fixating screw and/or the tack and/or to see the bone whendrilling a hole for the fixating screw and/or the tack. The fixatingscrew and/or the tack can protrude through the gums to the oral cavity,so the gums will heal around the fixating screw and/or the tack.

The container can be used in an open sinus lift procedure called alsoopen sinus augmentation procedure. After opening a lateral window in thelateral wall of the maxillary sinus and elevating the Schneiderianmembrane, the container can be inserted through the opening in thelateral wall and to be placed above the floor of the maxillary sinus andbelow the elevated Schneiderian membrane. The container can be insertedalready filled with bone augmenting material and/or can be filled afterbeing inside the maxillary sinus. The container can be placed while theside with the two membranes will face the opening in the lateral wall ofthe maxillary sinus and/or the Schneiderian membrane and/or a tear inthe Schneiderian membrane.

The container can be inserted inside the sinus in case when theSchneiderian is intact and wasn't torn during its elevation. Thecontainer can be inserted inside the sinus in cases when theSchneiderian membrane was torn during its elevation and/or in cases whenthe Schneiderian was damage and/or absent before the beginning of thesurgical procedure. In cases when the Schneiderian membrane is tornand/or absent it is recommended to fixate the container to be in contactwith the floor of the maxillary sinus. There are several options tofixate the container. For example, a dental implant and/or severaldental implants can be inserted through the maxillary alveolar ridge andthe floor of the maxillary sinus and inside the container. For example,the container can be fixated using screws which are used to fixate boneblocks. For example, the container can be fixated using screws or tackswhich are used to fixated GBR membranes, while the screw and/or thetacks can be inserted from inside the sinus towards the oral cavityand/or from the oral cavity towards inside the si nus.

The container can be fixated using sutures and/or wires. In oneembodiment illustrated in FIG. 12 , a fixating hole 121 and/or severalfixating holes can be drilled adjacent to the opening 122 in the lateralwall 123 of the maxillary sinus. A suture 124 can be connected to thecontainer 125 (the container is illustrated in FIG. 12 for clarificationpurposes although the container is inside the sinus and its boundariesusually can't be seen in this lateral view. In this view only the partof the container 125 which is adjacent the opening 122 can be seen) andpassed through the fixating hole 121. The suture 124 can be passedthrough the opening 122 in the lateral wall of the maxillary. The suturecan be tied and therefore fixating the container and keeping it incontact with the floor 126 of the maxillary sinus (illustrated in adotted line in FIG. 12 , the floor of the maxillary sinus usually can'tbe seen in this lateral view).

Usually it will be more comfortable to partially or completely fill thecontainer after its insertion inside the maxillary sinus. In anotherembodiment the container can have a side opening at one of it sides—themiddle region and/or the soft tissue blocking region, to enable fillingthe container. This filling can be in addition to filling through anopening at the edge of the bag, as described above. This filling througha side opening can be instead of filling through an opening at the edgeof the bag. The bag can be marketed closed at its both edges and filledthrough the side opening.

The side opening can be at the soft tissue blocking region so the first(inner) sheet (or the first side region) has an opening which can beaccessible through the second sheet (or the second side region). Theside opening can be covered by a retractable and/or movable piece ofmembrane—a retractable cover, that is attached to the container and canbe moved to reveal the opening to allow insertion of a bone materialinside the bag and then the retractable cover can be returned to itsplace to close the side opening.

The side opening in the soft tissue blocking region can be covered bytwo retractable and/or movable pieces of membrane—retractable covers. Afirst retractable cover of the first (inner) sheet (or the first sideregion) and a second retractable cover of the second (outer) sheet (orthe second side region. The second retractable cover can be larger thanthe first retractable cover so the borders of the second retractablecover can be over the first sheet around the borders of the firstretractable cover, so the first retractable cover being partially orfully cover by the second retractable cover. This configuration can bemore efficient in closing the side opening to prevent leakage of bonematerial from the container through the side opening.

The first and second retractable covers can be designed to be retractedto different direction. For example, the first retractable cover can beconnected to the first sheet close to the right border of the containerand to be retracted in the right direction, while the second retractablecover can be connected to the second sheet close to the left border ofthe container and to be retracted in the left direction. In anotheroptional configuration, the first retractable cover can be connected tothe first sheet closer to a first edge of the container and to beretracted towards the first edge, while the second retractable cover canbe connected to the second sheet closer to the second edge of thecontainer and to be retracted towards the second edge. Thisconfiguration of different directions of folding the retractable covers,can be more efficient in closing the side opening to prevent leakage ofbone material from the container through the side opening.

The first sheet can have also a slot between the opening in the firstsheet and the border of the first sheet so the second retractable coverwill be inserted through this slot to better fixate the secondretractable cover to prevent its dislocation during insertion of thecontainer inside a subperiosteal tunnel. The second and/or the firstretractable covers can be sutured and/or glued to the container forimproved fixation. The retractable covers can have variable shapes forexample, circular, oval, elliptic, rectangular and/or any tongue likeshape which is connected at one side to the container.

The side opening can be adjacent to the center of the container oradjacent to the edges of the container. For augmentation of the jawbones as described above it can be more convenient in some cases thatthe side opening being adjacent to one of the edges of the container. Inthis configuration, when both edges are already closed, the surgeondoesn't need to close the bag after filling through the side opening.For sinus lift procedures it can be more convenient in some cases thatthe side opening being adjacent to center of the container. One edge canbe open to allow initial filling through an opening in the edge of thecontainer and after the insertion inside the sinus the container can befilled through the side opening. If both edges of the container areclosed, the initial filling and/or the filling after the insertion ofthe container inside the maxillary sinus can be through the sideopening. In one embodiment of a container for sinus lift, the width ofthe middle region is smaller than the width of the side regions so thesoft tissue blocking region is larger than the middle region and it isfacing the Schneiderian membrane and the opening 122 in maxillary wallsinus 123 while the middle region is facing the floor 126 of themaxillary sinus. In another embodiment of a container for si nus lift,the width of the middle region is larger than the width of the sideregions so the soft tissue blocking region is smaller than the middleregion and it is facing the opening 122 in maxillary wall sinus 123while the middle region is facing the floor 126 of the maxillary sinusand the Schneiderian membrane.

It is possible to place additional membrane to close the opening in themaxillary sinus, however since the bone inside the container is alreadycovered by at least one membrane and in most places by two membranes theadvantages of additional membrane are less significant.

FIG. 13 illustrates an embodiment of a sheet and/or a membrane forpreparing a container with a side opening. The sheet 130 has a middleperforated region 131 with several holes, a first side region 133, asecond side region 134, a first closing extension 135 and a secondclosing extension 136. The sheet can include also connecting extensionsand compatible slots as described above and not illustrated in FIG. 13 .The first side region 133 can include a non-linear slot or severalconnected slots 137 surrounding partially a piece of the first sideregion 133 so this piece of the first side region 133 can be elevatedfrom the first side region 133 while being connected to the first sideregion 133 to form a first retractable cover 138. The second side region134 can include a non-linear slot or several connected slots 141covering partially a piece of the second side region 134 so this pieceof the second side region 134 can be elevated from the second sideregion 134 while being connected to the second side region 134 to form asecond retractable cover 139. The first side region 133 can have also acover fixating slot 140 to fixate the second retractable cover 139 afterpreparing a container from the sheet 130 and filling the container withbone augmenting material.

FIG. 14 illustrates a container 142 prepared from the membrane or sheet130 of FIG. 13 . In this embodiment one edge opening 143 is still openand the second closing extension 136 is prepared to close the edgeopening 143. The second side region 134 cover the first side region 133to form the soft tissue blocking region 144. In the soft tissue blockingregion 144, the first retractable cover 138 and the second retractablecover 139 being retracted to reveal the side opening 145. The middleperforated region 131 can be seen through the edge opening 143 andthrough the side opening 145.

FIG. 15 illustrates the container 150 after being filled and the edgeopening 143 of the container of FIG. 14 being closed and the sideopening 145 of the container of FIG. 14 being covered by the secondretractable cover 139. The side opening 145 can be also covered by thefirst retractable cover 138 which is not illustrated in FIG. 15 forbeing covered by the second retractable cover 139. If the container isfor use during a sinus lift procedure the side opening can be placed tobe accessible through the opening in the maxillary sinus wall.

The container can be fixated to the floor of the maxillary sinus and/orthe lateral wall of the maxillary sinus as described above, for exampleby using a fixating hole and sutures and/or wires. It is also possibleto retract one of the retractable covers 138, 139 while leaving theother retractable cover over and closing the side opening 145. Theretracted cover can be fixated to the floor of the maxillary sinusand/or the lateral wall of the maxillary sinus, for example by tacks. Itis also possible to close the side openings of the container 140 of FIG.14 without using the closing extensions 135, 136 of FIG. 13 . The edgescan be closed as explained above, for example by suturing. In thisembodiment the closing extensions can be used to fixate the container,for example by tacks inserted through the closing extensions and thelateral wall 123 of the sinus.

The container can be used also for treatment of other tissues. Forexample, a similar container having holes on one side can be filled withchondrocytes and place in the knee so the perforated side is towards thejoint and the blocking region is towards the skin to encourageregeneration of cartilage. Similar treatment can be done in the in otherjoints.

The container can be placed between two tissues or organs and filledwith medications that are intended for the treatment of one tissue, sothe perforated side of the container will face the tissue that requiresthe treatment without influencing the second tissue or organ.

The sheet can be made from a materials that blocks radiation and thecontainer can be placed between two tissues or organs and filled with aradiation emitting material that is intended for the treatment ofmalignancy in one tissue, so the perforated side of the container willface the tissue that requires the treatment without influencing anddamaging the second tissue and/or organ. In one embodiment the sheet canbe made at least partially from metal foils. In another embodiment thesheet can be made at least partially from one of the materials of guidedbone regeneration membranes as mentioned above, like collagen andmolecules and/or particles and/or fibers of radiation blocking material.The material s of the sheet can be bio-dissipative while the radiationblocking particles or fibers will remain without damaging thesurrounding organs. Such a container can be placed for example betweenthe prostate and the rectum while treating the prostate and protectingthe rectum.

What is claimed is:
 1. A method for treating patients in need for boneregeneration in the lower jawbone comprising: a. detaching a lingualperiosteal tissue from a lingual surface of said lower jawbone to form alingual opening between said lingual periosteal tissue and said lingualsurface of said lower jawbone; b. forming a subperiosteal tunnel throughsaid lingual opening, said subperiosteal tunnel extends from saidlingual opening along a segment of said lower jawbone and a segment of aperiosteal tissue; c. inserting through said lingual opening a baginside said subperiosteal tunnel, said bag has a perforated regionhaving holes which are larger than 30 microns, said bag has a softtissue blocking region in which holes which are larger than 20 micronsare absent, said bag contains a bone augmenting material, saidperforated region of said bag being placed towards at least part of saidsegment of said lower jawbone, said soft tissue blocking region beingplaced towards at least part of said segment of said periosteal tissue;d. closing said lingual opening and leaving said bag adjacent saidsegment of said lower jawbone for at least several days to allow bonetissue ingrowth through said holes inside said bag.
 2. The method ofclaim 1, wherein said segment of said periosteal tissue being locateddistally to said lingual opening.
 3. The method of claim 1, wherein anadditional bone augmenting being inserted inside said subperiostealtunnel between said bag and said segment of said lower jawbone.
 4. Themethod of claim 1, wherein an opening to said subperiosteal tunnel isbeing formed also at a buccal aspect of said lower jawbone.
 5. Themethod of claim 1, wherein said subperiosteal tunnel is extended to anocclusal aspect of said segment of said lower jawbone, said bag beingplaced along said occlusal aspect of said segment of said lower jawbone.6. The method of claim 1, wherein said subperiosteal tunnel is extendedto a buccal aspect of said segment of said lower jawbone, said bag beingplaced along said buccal aspect of said segment of said lower jawbone.7. The method of claim 1, wherein said bag being fixated to said lowerjawbone using a bone tack.
 8. The method of claim 1, wherein said bagbeing fixated to said periosteal tissue using a suture.
 9. The method ofclaim 1, wherein said bag being filled using a syringe having said boneaugmenting material.
 10. The method of claim 1, wherein said perforatedregion has more than 10 holes.
 11. The method of claim 1, wherein saidholes having diameter of 800 microns-2500 microns.
 12. The method ofclaim 1, wherein holes which are larger than 10 microns are absent fromsaid soft tissue blocking region.
 13. The method of claim 1, wherein atleast part of said soft tissue blocking region is made from a guidedregeneration membrane.
 14. The method of claim 1, wherein at least partsaid soft tissue blocking region has a first sheet and a second sheetabove said first sheet.
 15. The method of claim 14, wherein said firstsheet is connected to said second sheet by sutures.
 16. The method ofclaim 15, wherein said perforated region includes an edge closingextension, said edge closing extension being placed between said firstsheet and said second sheet to form said bag.
 17. The method of claim 1,wherein one edge of said perforated region being connected to said softtissue blocking region to form said bag having a filling openingadjacent the opposite edge of said perforated region.
 18. The method ofclaim 1, wherein said perforated region includes an edge closingextension, said edge closing extension being placed above at least partof said holes in said perforated region to form said bag.
 19. The methodof claim 1, wherein said bone augmenting material includes aparticulated bone augmenting material, the diameter of the particles ofsaid bone augmenting material are larger than the diameter of said holesin said perforated region.
 20. The method of claim 1, wherein said boneaugmenting material includes a particulated bone augmenting material,the diameter of the particles of said bone augmenting material aresmaller than the diameter of said holes in said perforated region andsaid particles are in a flowable material.